Community Outreach for Palliative Engagement -- Parkinson Disease (COPE-PD)

University of Rochester

Status: Enrolling

Conditions: Multiple System Atrophy; Vascular Parkinsonism; Corticobasal Degeneration; Lewy Body Parkinsonism; Parkinson Disease; Dementia With Lewy Bodies; Parkinson Disease Dementia; Progressive Supranuclear Palsy; Parkinson's Disease and Parkinsonism

Treatments: Other: Parkinson Disease Standard Care; Other: Online Community-Supported Palliative Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05222386

STUDY6775

Details and patient eligibility

About

The purpose of this study is to learn more about the effectiveness of palliative care training for community physicians and telemedicine support services for patients and carepartners with Parkinson's disease and Lewy Body Dementia (LBD) or related conditions and their care partners. Palliative care is a treatment approach focused on improving quality of life by relieving suffering in the areas of physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Telemedicine is the use of technology that allows participants to interact with a health care provider without being physically near the provider.

Full description

Investigators propose to conduct a pragmatic stepped-wedge comparative effectiveness trial comparing a novel model of providing community-based palliative care for persons living with Parkinson's disease (PD), Lewy Body Dementia (LBD) and related disorders through online communities to usual care. Our intervention includes support for both community neurologists (using the ECHO model of clinician support) as well as family caregivers and patients. Investigators hypothesize that this model of care will improve patient quality of life and caregiver burden as well as other important secondary outcomes such as patient symptom burden and clinician burnout. This study will recruit neurology providers (MD and APPs) from 24 community neurology practices. These practices will identify participants for the study who have PD, LBD or a related condition and moderate to high palliative care needs. Under usual care, community providers will deliver their usual care and center coordinators will collect data on our outcomes every 3 months. After one year of baseline data collection, 6 practices will be randomized to the intervention, which will include clinician training and coaching as well as access to online services for their patients. Per the stepped-wedge design an additional six practices will be randomized 18 months into the data collection period, six at 24 months, and the final six will enter the intervention 30 months into the data collection period to allow for 12 months intervention recruitment for all practices.

Enrollment: 710 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

PATIENT INCLUSION CRITERIA:

• Over age 40 years and diagnosed with PD or other causes of parkinsonism, such as progressive supranuclear palsy, multiple system atrophy and Lewy Body Dementia by their community neurologist.

Exclusion criteria

PATIENT EXCLUSION CRITERIA:

• Potential patient subjects who are unable or unwilling to commit to study procedures
• Presence of additional medical illnesses which requires palliative services (e.g. metastatic cancer)
• Already receiving palliative care or hospice services.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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710 participants in 2 patient groups

Usual Care

Other group

Description:

Community neurologists provide their usual care to enrolled participants. The clinicians may utilize other community resources to support patients and families as per their usual practice.

Treatment:

Other: Parkinson Disease Standard Care

Online Community-Supported Palliative Care Intervention

Other group

Description:

Community neurologists get training in palliative care via teleconferences (ECHO model), in addition to other support from our team. Patients and carepartners will also have access to additional support services when their providers enter the intervention (Online support groups, tailored education)

Treatment:

Other: Online Community-Supported Palliative Care